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FDA 510(k)

SURESHARP

K-Number: K950159 · 1995-04-14

ApplicantGainor Medical U.S.A., Inc.
Decision Date1995-04-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURESHARP is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical U.S.A., Inc.. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K950159. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURESHARP?

SURESHARP is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is Gainor Medical U.S.A., Inc.. The 510(k) number is K950159.

When did SURESHARP receive FDA 510(k) clearance?

SURESHARP received FDA 510(k) clearance on 1995-04-14, under 510(k) number K950159.

Who is the listed applicant for SURESHARP?

The FDA 510(k) record lists Gainor Medical U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURESHARP?

The FDA product code for SURESHARP is FMI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Gainor Medical U.S.A., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K944824SUREWING

Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261266MOWANA™ Auto DuoPENTAMASTER MEDIQ SDN BHDK261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd.K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)Hh Global Technology, Inc.K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd.K260739Profoject™ Pen Needles (Model A; Model B)CMT Health PTE., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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